1. Field of the Invention
This invention relates generally to a penile prosthesis for improved function and appearance, and more particularly to a subcutaneous penile implantation system that may be reversed without permanent tissue damage to the patient.
2. Description of Related Art
The following art defines the present state of this field:
Small et al, U.S. Pat. No. 3,893,456 describes a prosthesis for implantation in the penis to provide a flaccid penis with rigidified dimensions of length and of width, and with the property of flexural stiffness. The prosthesis is used in pairs, each of which is a one-piece member that includes a composite rod having a dimension of axial length and, for the major proportion of its length, is composed of two physically distinct bodies which are integrally joined to each other, one of which is more resistant to bending and to compressive deformation than the other, and a prong extending from said rod, said prong decreasing in lateral cross-section as it extends away from the rod. One of the bodies is stiffly flexible. In the preferred embodiment of the invention, the first of the bodies is a tube of solid material having an inner wall and an outer wall, the inner wall defining an axially extending cavity, the second body filling the cavity, the said first body being the one which is stiffly flexible. The second body is preferably made of a gel or of a foam.
Finney, U.S. Pat. No. 4,204,530 discloses an implantable sleeve for increasing the penile diameter. The sleeve includes a flexible sheet of soft, physiologically acceptable implantable material, the sheet being of sufficient length when formed in the general shape of a cylindrical sleeve to extend from the glans penis to the base of the penis, and of a width which is insufficient to completely encircle the penis, but sufficient to cover the corpora cavernosa. The sheet preferably has edges which are rounded and tapered side edges. The sleeve also includes suturing strips on the inside wall of the sleeve, adjacent the side edges of the sheet, which facilitate the suturing of the sheet to the tunica albuginea. The sleeve further includes porous patches located on the interior of the inside wall of the sleeve into which fibroblasts from the underlying tissues can grow to further anchor the sleeve to the tunica albuginea. In the preferred embodiment, the sheet is of very soft, medical grade silicone elastomer, and suturing strips are of Dacron(tm) fabric and the porous patches are of Dacron(tm) fabric or fluff.
Fogarty, U.S. Pat. No. 4,566,446 describes a penile prosthesis which is adapted for surgical implantation including a pair of fluid fillable prosthetic members and a fluid reservoir containing a supply of the fluid. A pump pumps fluid from the reservoir to the prosthetic members. The pump includes a valving section which is fluidly connected with the reservoir and the prosthetic members, and a pumping section for pumping the fluid from the reservoir to the prosthetic members. The valving section includes a deformable housing with a supply inlet passage fluidly connected to the reservoir and two outlet passages, each outlet passage fluidly connected to a corresponding prosthetic member. Each passage has a check valve for directing the flow of fluid from the reservoir, through the pumping section and into the prosthetic members. When the valving section is manually deformed, the check valves are placed in an inoperable state permitting flow of the fluid from the prosthetic member, through the pumping section, and back into the reservoir.
Cowen, U.S. Pat. No. 5,063,914 describes an apparatus for the treatment of male impotence. The apparatus has a cylinder of a biocompatible polymer which is implanted in the corpus cavernosum of the penis. The cylinder is attached at its proximal end to a base mount which is implanted in the pelvic area. In the flaccid state, the cylinder is empty and limp, and a spring within the cylinder folds the cylinder wall in upon itself to decrease its effective length. Fluid is pumped into the cylinder causing it to stiffen in the erect state. The effective length of the cylinder is increased by the addition of the fluid which compresses the internal spring and unfolds the cylinder. In this manner, the length of the penis is increased from the flaccid to the erect state.
Benderev et al., 5,611,515 describes the surgical treatment of stress urinary incontinence. The disclosed methods include: 1) a technique of probe passage to avoid injuring the bladder and to provide a more accurate and reproducible capture of the pubocervical fascia lateral to the bladder neck and urethra, 2) anchor fixation of the suspending sutures to the pubic bone to decrease the risk of suture pull through from above and to decrease post-operative pain and 3) a simple and reproducible technique to set a limited tension of the suspending sutures. A description of these methods and results of procedures with some of these methods are disclosed. Novel drill guides, suture passers, suture tensioners, and various related tools and devices for use in the surgical method are also disclosed.
Elist, U.S. Pat. No. 5,899,849 describes a penile prosthesis device and a method for surgical installation. The prosthesis device is designed to be subcutaneously implanted into a penis above the corpus cavernosum and extending from the base of the penis to the glans penis. The prosthesis device contains one or more inflatable tubular sacks for enabling an erectile function of the penis, and these are covered by a shaped body for enabling an improved appearance, texture and size to the penis. Integral with the tubular sack is a base which is sutured to the pubic bone. The invention includes a manual pump preferably implanted into the scrotum and interconnected with the base means by a tube, used to inflate the tubular sacks. A fluid is pumped by the pump through the tube, through the base, and into the inflatable tubular sacks for pressurization thereof so as to cause the tubular sacks to achieve rigidity, thereby causing the penis to become erect. If the pump is not large enough to contain enough fluid to inflate the inflatable tubular sack, the invention includes a reservoir that feeds into the pump.
The prior art teaches a device similar to the present invention in the Elist reference, 5,899,849. However, the present invention is an improvement thereof. The improvement includes an improved mounting apparatus for attachment of the invention to the bone structure of the patient, an improvement in the structure of the prosthesis making it easier to attach, and also includes an improved operational orientation of the penile implant portion of the apparatus for superior function with respect to the ""849 apparatus. The prior art does not teach these improvements.
The present invention teaches certain benefits in construction and use which give rise to the objectives described below.
The present invention provides a penile prosthesis device designed to be subcutaneously implanted into the penis and attached to the pubic bone. The device provides a pair of inflatable tubular members enabling an erectile function of the penis. A shaped body portion enables improvements in appearance, texture and size of the penis. Integral with the tubular members is a base for mounting the device to a mounting plate which is, in turn, attached to the pubic bone. The invention also includes a manual pump implanted into the scrotum and interconnected with the base via a flexible tube. This is used to inflate the tubular members. A fluid is pumped through the tube, into the base, and thus into the inflatable tubular members for pressurization thereof. As the tubular members straighten and fill, the penis achieves its full diameter and is lifted into an erect position.
A primary objective of the present invention is to provide an erection enhancing prosthesis which can be implanted subcutaneously in the penis and is therefore later removable should complications arise, i.e., a reversible procedure may be performed without permanent damage to the penis.
A further objective is to increase the length and girth of the penis without causing structural damage to the penis.
Another objective is to provide a prosthesis capable of maintaining a smooth, natural look and feel, both while flaccid and while inflated.
A still further objective is to teach an improved mounting structure for the implant.
A final objective is to teach an improved operational orientation of the erectile member of the invention relative to its mounting base and source of hydraulic fluid.
Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.